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General information
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26
26
2018-10-23, 1397/08/01
2018-11-03, 1397/08/12
2018-1011-2303 00:00:00
empty
2018-12-01, 1397/09/10
2018-12-01 00:00:00
empty
2019-06-29, 1398/04/08
2019-06-29 00:00:00
empty
2019-08-14, 1398/05/23
2019-08-14 00:00:00
empty
The start and end dates of patient recruitment and the end date of the clinical trial were recorded.
The start and end dates of patient recruitment and the end date of the clinical trial were recorded.
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تاریخ شروع و اتمام نمونه گیری و تاریخ پایان کارآزمایی بالینی ثبت شد.
تاریخ شروع و اتمام نمونه گیری و تاریخ پایان کارآزمایی بالینی ثبت شد.
The effect of hybrid knee brace on coping ability and neromuscular parameters after acute anterior cruciate ligament tear
The effect of hybrid knee brace on coping ability and neuromuscular parameters after acute anterior cruciate ligament tear
The effect of hybrid knee brace on coping ability and neromuscularneuromuscular parameters after acute anterior cruciate ligament tear
Protocol summary
Study aim
The effect of hybrid knee brace, consisting of a functional brace and an elastic sleeve, after acute rupture of ACL, on coping ability and neuromuscular parameters after acute injury of the anterior cruciate ligament.
Design
Clinical trial with community based and practice-oriented test and control group, with parallel groups, single-blind, simple randomization method
Settings and conduct
Sampling at Shafa Yahyaiyan Hospital, evaluation at the Sport Sciences Research Institute of Iran by the Biodox system 4 dynamometer and relevant questionnaires, tests include maximum muscle strength of the quadriceps, then 30% and 50% of MVC for assessing steadiness of Quadriceps, duration of 6-meter single-leg hop test will be recorded, one-way blindness
Participants/Inclusion and exclusion criteria
Inclusion criteria: people between 18 to 40 years old; unilateral and isolated ACL rupture; maximum three months after injury; 3-5 grade of the Tagner Questionnaire; no cartilage damage; lack of fracture or dislocation; no history of fracture and previous surgery in the knee joint; no history of previous ACL or meniscal or other ligaments injuries.
Exclusion criteria: unwillingness to continue cooperation; failure to comply with the rehabilitation protocol; knee pain and inflammation during the performance tests.
Intervention groups
Samples allocation from patients with complete anterior cruciate ligament rupture referring to the knee clinic at Shafa Yahyayan Hospital. The intervention in the test group includes a custom knee brace fabricated by taking measures of the individual's body, plus an appropriate size of sleeve, In the control group, there is no orthosis intervention, and people receive only physical therapy.
Main outcome variables
Coping condition of patients; Tampa questionnaire score; duration of a six-meter hop test; steadiness of the sub maximal muscular force of the quadriceps
General information
Reason for update
The start and end dates of patient recruitment and the end date of the clinical trial were recorded.
Acronym
IRCT registration information
IRCT registration number:IRCT20181003041219N1
Registration date:2018-11-03, 1397/08/12
Registration timing:prospective
Last update:2020-04-14, 1399/01/26
Update count:1
Registration date
2018-11-03, 1397/08/12
Registrant information
Name
Zahra Nemati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8844 4530
Email address
zhrnem@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-03, 1397/08/12
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
2018-12-01, 1397/09/10
Actual recruitment end date
2019-06-29, 1398/04/08
Trial completion date
2019-08-14, 1398/05/23
Scientific title
The effect of hybrid knee brace on coping ability and neuromuscular parameters after acute anterior cruciate ligament tear
Public title
The effect of hybrid knee brace on acute anterior cruciate ligament tear
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Unilateral isolated tear of anterior cruciate ligament
Injury within last three month
Required 3-5 scores from Tegner questionnaire
Exclusion criteria:
The presence of damage to the meniscus confirmed by MRI
The presence of cartilage damage
The presence of fracture or dislocation with ACL rupture
The history of fracture and previous surgery in the knee joint
The history of previous ACL or meniscal or other ligaments injuries
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
26
Actual sample size reached:
26
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization method will be used. 26 cards, numbered from 1 to 26, are poured into the container. Then, each time, a card containing one number is randomly taken out of the container. In this way, 13 cards are selected and the registration number is considered as the numbers of test group. The remaining numbers in the container are considered as the control group. Subsequently, people entering the study according to inclusion criteria are randomized in the test or control group, respectively.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, blindness is done in one direction. So that the participants in the study do not know if they are in the control or test group. A specialist physician who will evaluate and refer patients will also be blind.
Placebo
Not used
Assignment
Parallel
Other design features
So far, a study based on orthosis intervention in the acute stage of the anterior cruciate ligament rupture has not been done to increase the number of copers. The result of the present study may increase the number of copers and reduce the likelihood of reconstruction surgery. Another aspect of this study is introducing a hybrid brace that benefits from the use of hard and soft braces simultaneously and also changes in the structure of the hard part for specific instability control after anterior cruciate ligament rupture. Finally, the effect of using the hybrid brace is evaluated by measuring the quadriceps steadiness, which indicates the level of coordination of the musculoskeletal system after the intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Hemmat highway
City
Tehram
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-07-10, 1397/04/19
Ethics committee reference number
IR.IUMS.REC.1397.049
Health conditions studied
1
Description of health condition studied
Anterior cruciate ligament rupture
ICD-10 code
S83.51
ICD-10 code description
Sprain of anterior cruciate ligament of knee
Primary outcomes
1
Description
Quadriceps steadiness
Timepoint
Acute stage
Method of measurement
Biodex dynamometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Individuals with acute anterior cruciate ligament rupture, intervention including using a hybrid brace for one month, and performing routine physiotherapy for ten sessions to reduce pain, edema and increase knee range of motion, then determine the person's compatibility with injury and measure the stability of the quadriceps muscle by Biodex Isokinetic dynamometer
Category
Rehabilitation
2
Description
Control group: Individuals with acute rupture of the anterior cruciate ligament, routine intervention including ten sessions of physiotherapy to reduce pain, edema and increase knee range of motion, then determine the person's compatibility with injury and measure the stability of the quadriceps muscle by Biodex Isokinetic dynamometer
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Yahyaiyan hospital
Full name of responsible person
دکتر ابولفضل باقری فرد
Street address
Mujahideen Islam Street
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 3354 2001
Email
zhrnem@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Seyed Kazem Malakooti
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?